A Study of [225Ac]-FPI-1966 in Participants With Advanced Solid Tumours

  • STATUS
    Recruiting
  • End date
    Dec 16, 2026
  • participants needed
    155
  • sponsor
    Fusion Pharmaceuticals Inc.
Updated on 16 May 2022
renal function
monoclonal antibodies
measurable disease
growth factor
immunohistochemistry
FGFR3

Summary

This is a first-in-human, Phase 1/2, non-randomized, multi-centre, open-label clinical study designed to investigate safety, tolerability, dosimetry, biodistribution, and PK of [225Ac] FPI-1966, [111In]-FPI-1967, and vofatamab and the preliminary anti-tumour activity of [225Ac]-FPI-1966 in participants with FGFR3-expressing advanced, inoperable, metastatic, and/or recurrent solid tumours. Phase 1 consists of five multiple dose escalation cohorts. Phase 2 consists of two tumour-specific cohorts and one basket cohort.

Description

The potential impact of pre-dose administration of vofatamab on the dosimetry, PK, safety, and tolerability of [225Ac]-FPI-1966 and [111In]-FPI-1967 will be evaluated in Phase 1, Cohort 1 of the study. [225Ac]-FPI-1966 will be evaluated in Phase 1 across 5 planned, ascending dose cohorts using a 3 + 3 dose escalation design. Participants will receive 185 MBq of [111In]-FPI-1967 during the imaging screening period to determine biodistribution and estimate radiation exposure to critical organs.

Once the recommended phase 2 dose (RP2D) regimen is established and confirmed, three expansion cohorts may be initiated in parallel.

Details
Condition Advanced Solid Tumor, Head and Neck Squamous Cell Carcinoma, Bladder Carcinoma, Susceptible FGFR3 Genetic Alterations, FGFR3, FGFR3 Overexpression, FGFR3 Receptor, FGFR3 Protein Overexpression, Ovarian Cancer, Colorectal Cancer, Breast Cancer, Liver Cancer, Lung Cancer, Gastric Cancer
Treatment Vofatamab, [225Ac]-FPI-1966, [111In]-FPI-1967
Clinical Study IdentifierNCT05363605
SponsorFusion Pharmaceuticals Inc.
Last Modified on16 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Signed ICF prior to initiation of any study-specific procedures
Male and female participants, ≥ 18 years of age, with Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Histologically and/or cytologically documented diagnosis of locally advanced, inoperable, or metastatic solid tumours
Refractory to all standard treatments, or for whom standard treatment is not available, or tolerable, or is contraindicated, or the participant refuses standard therapy
Measurable disease per RECIST v. 1.1 with at least one non-nodal lesion of ≥ 20 mm in the longest diameter
Available tumour tissue (either archival within the last two years or fresh biopsy) for FGFR3 immunohistochemistry and biomarker analysis (submission of tissue not required prior to enrolment)
Adequate bone marrow, cardiovascular, hepatic, and renal function

Exclusion Criteria

Prior systemic radiopharmaceutical therapy within six months prior to the first dose of [111In]-FPI-1967
Prior radiation therapy (RT) to bone marrow > 20 Gy
RT within 30 days prior to the first dose of [111In]-FPI-1967
Prior anti-cancer treatment (chemotherapy, immunotherapy, hormonal therapy, targeted therapy, or investigational agents) within five half-lives or four weeks, whichever is shorter, prior to administration of the first dose of [111In]-FPI-1967
Concurrent serious co-morbidities that could limit participants' full participation and compliance
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